Transcription of Annex 7 - WHO
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Annex 7 - WHO
131 Annex 7 Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability11 Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. In: WHO Expert Committee on Specifications for Pharmaceutical Products: fortieth report. World Health Organization: Geneva; 2006: Annex 7 (WHO Technical Report Series, No. 937).1. Introduction 1342. Glossary 1353. Documentation of equivalence for marketing authorization 1394. When equivalence studies are not necessary 1405. When equivalence studies are necessary and types of study required In vivo studies In vitro studies 1426. In vivo equivalence studies in humans General considerations Provisions for studies in humans Justification of human bioequivalence studies Selection of investigators Study protocol 1437.
Annex 7 133 10.3.3 Dissolution profile comparison for biowaivers based on dose- proportionality of formulations 177 10.4 In vitro equivalence testing for non-oral dosage forms 177 10.5 In vitro equivalence testing for scale-up and post-approval changes 180 References 180 Appendix 1 Recommendations for conducting and assessing comparative
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